Sr. Clinical Project Associate
Proclinical is currently recruiting for a Senior Clinical Project Associate with a leading pharmaceutical company located remotely. As the Senior Clinical Project Associate, you will assist the CPLs for the planning, implementation, execution and compliance of operational plans for clinical study/program with multiple clinical vendors in order to maintain inspection readiness.
- Customize and update any study-specific plans and process flows for multiple clinical vendors, as appropriate.
- Ensure quality of the trial master file through QC review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted.
- Assist CPL by tracking compliance to all study level plans and escalating any variances.
- Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
- Ensure CRA compliance with the study parameters via review of monitoring visit reports.
Skills and Requirements:
- Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
- 3+ years of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development.
- Work with CROs and vendors to drive timelines and deliverables.
- Experience working with study budgets and forecasting; contract and invoice review.
- Research certification desirable.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.